Class 3 Device Recall Stryker Howmedica Osteonics

• Date Initiated by Firm: December 02, 2002
• Date Posted: January 28, 2003
• Recall Status: Terminated on August 01, 2003
• Recall Number: Z-0467-03
• Recall Event ID: 25321
• 510(K)Number: K944836
• Product Classification: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate - Product Code MEH
• Product: Restoration #8 HA Hip Stem, Catalog No. 6013-1216 and Restoration #8 HA Hip Stem, Catalog No. 6013-1218.
• Code Information: Catalog No. 6013-1216 -- Lot Code: 37778302; Catalog No. 6013-1218 -- Lot Code: 37778401.
• FEI Number: 3003070421
• Recalling Firm/ Manufacturer: Stryker Howmedica Osteonics; 300 Commerce Court; Mahwah NJ 07430
• For Additional Information Contact: Tom Grzeskowiak; 201-831-5495
• Manufacturer Reason for Recall: Product mix-up. 16mm stem in a 18mm package.
• FDA Determined Cause: Other
• Action: Branches and agents were notified via letter on 12/2/2002. Hospitals were notified on 12/2/2002 via FedEx to OR Supervisors.
• Quantity in Commerce: 6
• Distribution: The product was shipped to 2 Howmedica branches, 1 hospital, one government hospital, and 2 international distributors. Government hospital is the VA Medical Center, Tampa, FL.. Two international customers are Stryker Howmedica affiliates in Chile and Spain.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MEH